ADVANCED TIME ZONE AGE REVERSING LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN- avobenzone, octinoxate, and octisalate cream

Advanced Time Zone Age Reversing by

Drug Labeling and Warnings

Advanced Time Zone Age Reversing by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.00%	Sunscreen
Octinoxate 7.50%	Sunscreen
Octisalate 5.00%	Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
• children under 6 months of age: ask a doctor

Inactive ingredients

water\aqua\eau butylene glycol octyldodecyl myristate glycerin neopentyl glycol diheptanoate dimethicone glyceryl stearate polyethylene hydrogenated lecithin pentaerythrityl tetraethylhexanoate whey protein\lactis protein\proteine du petit-lait polygonum cuspidatum root extract humulus lupulus (hops) extract helianthus annuus (sunflower) seedcake punica granatum (pomegranate) fruit juice centaurium erythraea (centaury) extract lens esculenta (lentil) fruit extract pyrus malus (apple) fruit extract hordeum vulgare (barley) extract\extrait d'orge laminaria digitata extract cucumis sativus (cucumber) fruit extract laminaria saccharina extract tamarindus indica seed extract hydrolyzed rice extract litchi chinensis seed extract vitis vinifera (grape) seed extract rosmarinus officinalis (rosemary) extract selaginella tamariscina (spike moss) extract rosmarinus officinalis (rosemary) leaf extract citrus reticulata (tangerine) peel extract limonium vulgare flower/leaf/stem extract citrullus vulgaris (watermelon) fruite extract sigesbeckia orientalis (st. paul's wort) extract anthemis nobilis (chamomile) yeast extract\faex\extrait de levure linolenic acid cholesterol caffeine sucrose glucose isohexadecane chamomilla recutita (matricaria) sodium pca propylene glycol dicaprate caprylyl glycol acetyl glucosamine trehalose thermus thermophillus ferment phytantriol glucose oxidase di-c12-15 alkyl fumarate sodium hyaluronate sodium lactate linoleic acid adenosine phosphate peg-100 stearate tocopheryl acetate lactoperoxidase decarboxy carnosine hcl acetyl hexapeptide-8 behenyl alcohol pvp/hexadecene copolymer pentylene glycol hdi/ppg/polycaprolactone crosspolymer acrylamide/sodium acryloyldimethyltaurate copolymer polysilicone-11 cetyl alcohol carbomer pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate potassium hydroxide polysorbate 80 hexylene glycol potassium sulfate dextrin lecithin nordihydroguaiaretic acid cyclodextrin silica ethylbisiminomethylguaiacol manganese chloride disodium edta phenoxyethanol <iln39640>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Container Carton

EL

ESTĒE LAUDER

Advanced Time Zone
Age Reversing Line/Wrinkle Creme
Oil-Free
Broad Spectrum SPF 15

Normal/Combination Skin

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

ADVANCED TIME ZONE AGE REVERSING   LINE/WRINKLE OIL FREE BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
avobenzone, octinoxate, and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butylene glycol (UNII: 3XUS85K0RA)
octyldodecyl myristate (UNII: S013N99GR8)
glycerin (UNII: PDC6A3C0OX)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
dimethicone (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
HOPS (UNII: 01G73H6H83)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
POMEGRANATE JUICE (UNII: 99S671U9KB)
CENTAURIUM ERYTHRAEA (UNII: 57X4TSH58S)
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
APPLE (UNII: B423VGH5S9)
BARLEY (UNII: 5PWM7YLI7R)
laminaria digitata (UNII: 15E7C67EE8)
CUCUMBER (UNII: YY7C30VXJT)
SACCHARINA LATISSIMA (UNII: 68CMP2MB55)
TAMARIND SEED (UNII: 6AHP8A7OML)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ROSEMARY (UNII: IJ67X351P9)
TANGERINE PEEL (UNII: JU3D414057)
LIMONIUM VULGARE FLOWERING TOP (UNII: 840Y01ZC0M)
WATERMELON (UNII: 231473QB6R)
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
linolenic acid (UNII: 0RBV727H71)
cholesterol (UNII: 97C5T2UQ7J)
caffeine (UNII: 3G6A5W338E)
sucrose (UNII: C151H8M554)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
isohexadecane (UNII: 918X1OUF1E)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
propylene glycol dicaprate (UNII: U783H9JHWY)
caprylyl glycol (UNII: 00YIU5438U)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
trehalose (UNII: B8WCK70T7I)
phytantriol (UNII: 8LVI07A72W)
glucose oxidase (UNII: 0T8392U5N1)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
sodium lactate (UNII: TU7HW0W0QT)
linoleic acid (UNII: 9KJL21T0QJ)
adenosine phosphate (UNII: 415SHH325A)
peg-100 stearate (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
DOCOSANOL (UNII: 9G1OE216XY)
pentylene glycol (UNII: 50C1307PZG)
cetyl alcohol (UNII: 936JST6JCN)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
potassium hydroxide (UNII: WZH3C48M4T)
polysorbate 80 (UNII: 6OZP39ZG8H)
hexylene glycol (UNII: KEH0A3F75J)
potassium sulfate (UNII: 1K573LC5TV)
ICODEXTRIN (UNII: 2NX48Z0A9G)
MASOPROCOL (UNII: 7BO8G1BYQU)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-035-01	1 in 1 CARTON	05/01/2013
1		50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/01/2013

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-035) , REPACK(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-035) , REPACK(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-035) , REPACK(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-035)